TEMP Sr. Quality Specialist l, Manufacturing Quality

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    "datePosted": "2024-06-18T08:30:01.618Z",
    "description": "<h2>Overview</h2>\n<p><strong><u>Who We Are:</u></strong></p>\n<p> </p>\n<p>At Dendreon, we’re transforming the battle against cancer with personalized immunotherapy. Our flagship product, <strong>PROVENGE® (sipuleucel-T)</strong>, was the first FDA-approved immunotherapy for metastatic castrate-resistant prostate cancer, utilizing a patient’s own immune cells to fight the disease.</p>\n<p> </p>\n<p>If you’re driven by the opportunity to make a meaningful impact on cancer patients' lives, we invite you to join our team. With Immunotherapy Manufacturing Facilities in Seal Beach, CA, and Union City, GA, a strong Research & Development group in Seattle, WA, and a highly skilled Commercial team across the nation, Dendreon is at the forefront of cancer treatment innovation.</p>\n<p> </p>\n<p><strong><u>Core Values:</u></strong></p>\n<ul>\n <li><strong>Put Patients First: </strong>Every day is an opportunity to improve the lives of those living with cancer.</li>\n <li><strong>Act with Integrity: </strong>We commit to transparency, honesty, and always doing what’s right.</li>\n <li><strong>Build Trust: </strong>Trust is earned through candid, open communication and a collaborative approach.</li>\n <li><strong>Raise the Bar: </strong>We embrace continuous improvement and innovation, always striving to elevate our people.</li>\n <li><strong>Drive Results: </strong>We are accountable to each other and deliver success together.</li>\n</ul>\n<p><strong><u>Job Summary:</u></strong></p>\n<p>The TEMP Sr. Quality Specialist I, Manufacturing Quality, will perform a wide variety of QA activities to ensure compliance with applicable regulatory requirements.</p>\n<p> </p>\n<p><strong>NOTE:</strong> This is a <strong>TEMPORARY</strong> role from May to December 2026 and will be <strong>on-site at our Seal Beach, CA</strong> location.</p>\n<h2>Responsibilities</h2>\n<ul>\n <li>Perform activities related to batch record process flow (i.e. Issuance, Review, Closure).</li>\n <li>Perform incoming receipt of patient material and packing of Final Product.</li>\n <li>Perform Final Product disposition and release.</li>\n <li>Perform Raw Material review and approval.</li>\n <li>Review and approve GMP facility work orders.</li>\n <li>Review and approve system, equipment or method validation protocols, reports, and related validation documents (ie. Requalification, URS, FRS, RBRAs etc).</li>\n <li>Conduct product complaint investigations.</li>\n <li>Processes deviations and non-conformances.</li>\n <li>Track/trend metrics and reports data to Senior Management for escalation as necessary.</li>\n <li>Processes change controls (authors/review change impact and risk assessments).</li>\n <li>Provide support for any other duties assigned.</li>\n <li>Represents department in cross-functional teams, projects and GXP-related problem resolution.</li>\n <li>Uses professional concepts and company policies and procedures to solve a wide range of difficult problems in imaginative and practical ways.</li>\n <li>Works on problems of diverse scope in which analysis of data requires evaluation of identifiable factors. </li>\n <li>Exercises judgment within generally defined practices and policies in selecting methods and techniques for obtaining solutions.</li>\n <li>Normally receives no instructions on routine work, general instructions on new assignments.</li>\n</ul>\n<p> </p>\n<h2>Qualifications</h2>\n<p><strong><u>Education and Professional Experience:</u></strong></p>\n<ul>\n <li>Bachelor’s degree in a scientific discipline or equivalent.</li>\n <li>7+ years in a cGMP regulated environment with related experience within the biopharmaceutical or biotechnology industry preferred. 10+ years of relevant work experience can be substituted for a 4-year course of study leading to a Bachelor’s degree.</li>\n <li>Knowledge of current regulatory requirements in support of cGMP manufacturing operations (i.e., FDA and ICH guidelines).</li>\n <li>Experience in knowledge of sterile products aseptic manufacturing processes and testing preferred.</li>\n <li>Understanding of facility/building related knowledge (ISO classifications, air handling units, differential pressures.</li>\n <li>Proficient in MS Office applications.</li>\n <li>Ability to gown aseptically for work in Clean Room environments.</li>\n</ul>\n<p><strong><u>Working Conditions and Physical Requirements:</u></strong></p>\n<ul>\n <li>Limited use of laboratory equipment, chemicals and biological materials.</li>\n <li>Ability to sit or stand for extended periods of time. </li>\n <li>Intermittent walking to gain access to work areas.</li>\n <li>Finger dexterity sufficient to use a computer and to complete paperwork activities.</li>\n <li>Vision sufficient to use a computer, to read written materials and to complete paperwork activities.</li>\n <li>Hearing sufficient to communicate with individuals by telephone and in person.</li>\n <li>Ability to life up to 25 pounds. Limited exposure to (2C – 8C); (-20C).</li>\n <li>Job performed in a lab, office, or utility (noisy) environment.</li>\n <li>Must have the ability to work around laboratories, manufacturing areas and equipment with exposure to blood, blood products or OPIM (other potentially infectious materials) while donning required personal protective materials.</li>\n</ul>",
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